A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis

Psoriasis Clinical Trial

Official title:

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects With Moderate to Severe Psoriasis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05044234
• Other study ID #: M18-816
• Status: Terminated
• Phase: Phase 2
• Start date: November 16, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements assessed disease activity in participants with plaque psoriasis. Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each group received a different treatment. There was a 1 in 4 chance that participants were assigned to placebo. Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks. There may have been a higher burden for participants in this study compared to usual standard of care. Participants attended regular visits per routine clinical practice. The effect of the treatment was checked by medical assessments, checking for side effects, and questionnaires.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 156
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.

Exclusion Criteria:

• Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
• Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Cedirogant
Capsule, Oral
• Placebo
Capsule, Oral

Locations

Country	Name	City	State
Canada	SimcoDerm Medical and Surgical Dermatology Center /ID# 238861	Barrie	Ontario
Canada	Dr. Wei Jing Loo Medicine Prof /ID# 238865	London	Ontario
Canada	Lynderm Research Inc. /ID# 243199	Markham	Ontario
Canada	Dr. Chih-ho Hong Medical Inc. /ID# 238864	Surrey	British Columbia
Canada	K. Papp Clinical Research /ID# 239695	Waterloo	Ontario
Canada	Wiseman Dermatology Research /ID# 238867	Winnipeg	Manitoba
Japan	Hamamatsu University Hospital /ID# 239346	Hamamatsu-shi	Shizuoka
Japan	Kansai Medical University Hospital /ID# 239278	Hirakata-shi	Osaka
Japan	The Jikei University Hospital /ID# 239319	Minato-ku	Tokyo
Japan	Nagoya City University Hospital /ID# 239286	Nagoya shi	Aichi
Japan	Takagi Dermatology Clinic /ID# 239274	Obihiro-shi	Hokkaido
Japan	Okayama University Hospital /ID# 239285	Okayama-shi	Okayama
Japan	JR Sapporo Hospital /ID# 239277	Sapporo-shi	Hokkaido
Japan	NTT Medical Center Tokyo /ID# 239287	Shinagawa-ku	Tokyo
Japan	Tokyo Medical University Hospital /ID# 239320	Shinjuku-ku	Tokyo
Japan	Mie University Hospital /ID# 239275	Tsu-shi	Mie
United States	Arlington Research Center, Inc /ID# 244171	Arlington	Texas
United States	Orion Clinical Research /ID# 238619	Austin	Texas
United States	Bellaire Dermatology Associates /ID# 247865	Bellaire	Texas
United States	UAB Department of Dermatology /ID# 238563	Birmingham	Alabama
United States	Clinical Research Center of the Carolinas /ID# 238827	Charleston	South Carolina
United States	Darst Dermatology /ID# 238677	Charlotte	North Carolina
United States	Univ Hosp Cleveland /ID# 245953	Cleveland	Ohio
United States	Cleaver Medical Group Dermatology - Dawsonville /ID# 246327	Dawsonville	Georgia
United States	Zel Skin & Laser Specialists - Edina /ID# 238714	Edina	Minnesota
United States	Encino Research Center /ID# 245950	Encino	California
United States	Center for Clinical Studies - Houston (Binz) /ID# 243700	Houston	Texas
United States	Dawes Fretzin, LLC /ID# 238704	Indianapolis	Indiana
United States	Clinical Partners, LLC /ID# 238620	Johnston	Rhode Island
United States	Forest Hills Dermatology Group /ID# 238708	Kew Gardens	New York
United States	Marietta Dermatology Clinical Research /ID# 238679	Marietta	Georgia
United States	Dermatologists of Southwest Ohio, Inc /ID# 238939	Mason	Ohio
United States	Florida International Rsrch cr /ID# 245959	Miami	Florida
United States	Lakes Research, LLC /ID# 238831	Miami	Florida
United States	West Virginia Research /ID# 238517	Morgantown	West Virginia
United States	Tennessee Clinical Research Center /ID# 238682	Nashville	Tennessee
United States	Velocity Clinical Research, Inc. /ID# 239536	North Hollywood	California
United States	Arkansas Research Trials, LLC /ID# 238687	North Little Rock	Arkansas
United States	Skin Specialists, PC /ID# 238514	Omaha	Nebraska
United States	Medical Dermatology Specialist /ID# 238518	Phoenix	Arizona
United States	University of Pittsburgh MC /ID# 246170	Pittsburgh	Pennsylvania
United States	Oregon Dermatology and Research Center /ID# 238823	Portland	Oregon
United States	Health Concepts /ID# 238510	Rapid City	South Dakota
United States	Arlington Dermatology /ID# 238701	Rolling Meadows	Illinois
United States	Progressive Clinical Research /ID# 238565	San Antonio	Texas
United States	Medderm Associates /ID# 238834	San Diego	California
United States	Dermatology Specialists of Spokane /ID# 238809	Spokane	Washington
United States	Lenus Research & Medical Group /ID# 238695	Sweetwater	Florida
United States	Advanced Clinical Research Institute /ID# 238697	Tampa	Florida
United States	Clinical Research Trials of Florida, Inc. /ID# 238709	Tampa	Florida
United States	ForCare Clinical Research /ID# 238856	Tampa	Florida
United States	Buffalo Medical Group /ID# 239068	Williamsville	New York
United States	Wilmington Dermatology Center /ID# 246445	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.	Baseline, Week 16
Secondary	Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16	The static Physicians Global Assessment (sPGA) is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean =1.5, <2.5; Moderate (3) = mean =2.5, <3.5; and Severe (4) = mean =3.5.	At Week 16
Secondary	Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.	Baseline, Week 16
Secondary	Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.	Baseline, Week 16
Secondary	Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.	Baseline, Week 16
Secondary	Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline	The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms.	Baseline, Week 16
Secondary	Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) =4-Point Improvement From Baseline at Week 16 for Participants With Itch NRS =4 at Baseline	The itch NRS is an 11-point scale that participants completed to describe the intensity of their itch using a 24-hour recall period. The itch NRS asked the participants to: "Please rate your itching severity due to your psoriasis by circling the number that best describes your worst level of itching in the past 24 hours?" The itch NRS scale scores vary between 0, representing "no itching" and 10, representing "worst itch imaginable."	Baseline, Week 16